F.D.A. to Create Advisory Panel To Warn Patients About Drugs

By GARDINER HARRIS

Published: February 16, 2005

Responding to widespread criticism of the government's handling of drug safety problems, the Food and Drug Administration announced Tuesday that it was creating a board to advise it on drug complications and to warn patients about unsafe drugs.

Dr. Lester M. Crawford, the acting commissioner of the drug agency, said the board would be made up of scientists drawn from throughout the federal government. The board, which is to make its conclusions public on a Web page, will not have independent power to force the withdrawal of drugs but will simply advise the F.D.A., Dr. Crawford said.

In addition, he said, the agency will soon tap into large databases, including those at the Medicare agency, to uncover dangerous side effects in drugs already on the market. The agency said it would increase the number of fact sheets that patients receive with prescriptions.

The announcement comes as Congressional committees are investigating the agency's ability to discover drug dangers. It also comes on the eve of a landmark three-day advisory panel hearing into the safety of the pain pills Celebrex, Bextra and Vioxx, a hearing that could prove embarrassing to the agency.

Michael O. Leavitt, the secretary of health and human services, who made the announcement with Dr. Crawford at the agency's headquarters, said the measures were ''a response to a widely held concern both inside and outside Congress.''

Dr. Crawford, who was nominated Monday by President Bush to become the permanent commissioner of the F.D.A., noted that the agency had tended to keep secret potentially damning information about drugs until it decided what to make of it.

''Our culture, which has received some criticism in recent months, is not to alarm the public when we get a signal,'' Dr. Crawford said. ''That era is sort of past. What the public, we think, is demanding is to know as soon as we know what's going on. And they're fully prepared and adult enough to interpret whether or not this is a final decision.''

Like many of the F.D.A.'s recent actions, this one immediately drew criticism from advocates for drug safety and from academics.

The Office of Drug Safety at the agency now has about 109 employees and tries to uncover unknown drug dangers largely by poring over miscellaneous and haphazard injury reports sent in by doctors and drug companies. If a drug causes a reaction that is an otherwise common malady -- like a heart attack -- the Office of Drug Safety is almost powerless to uncover it. The office is part of the agency's drug review center.

Advocates have been calling for a more muscular drug safety center with far more employees that would be independent of the F.D.A. or at least independent of its drug review division. Neither characterizes the agency's board.

''It's being done as a substitute to fundamental change in the Office of Drug Safety, so it's unlikely to make any difference,'' Dr. Sidney M. Wolfe, a director of the consumer advocacy group Public Citizen, said. ''It's a cruel hoax and a frantic reaction to Congressional disapproval.''

Dr. Alastair Wood, an associate dean at Vanderbilt University who has long advocated an independent safety review board structured like the National Transportation Safety Board, said he was disappointed.

''This is not my concept of what an independent drug safety board would be,'' Dr. Wood said. ''This is a reshuffling of the deck.''

He added, ''It's a huge opportunity that's been lost to introduce transparency and restore confidence in the system.''

Academics say that tapping into large health databases to uncover drug dangers would probably cost tens of millions of dollars each year. The administration's 2006 budget proposal includes no additional money for such an expense. An agency spokesman said the money ''would come from existing resources.''

Senator Charles E. Grassley, Republican of Iowa, who has been investigating the F.D.A. for a year, said that Dr. Crawford's initiative, while welcome, did not go far enough. Mr. Grassley said legislation was needed to make the Office of Drug Safety independent of the drug review center, which approves drugs before marketing.

''I'm drafting legislation to clearly establish this independence and provide the office the authority needed to do its job,'' Mr. Grassley said.

Senator Edward M. Kennedy, Democrat of Massachusetts, said the F.D.A. needed to do more. ''It is critical that F.D.A.'s resources to monitor drugs be dramatically increased, and the F.D.A. must be given the authority to require drug companies to initiate and complete appropriate safety studies,'' Mr. Kennedy said.

The lack of new financing for drug safety efforts disappointed researchers who use databases to uncover unknown dangers of drugs.

Dr. Richard Platt of Harvard Medical School, one of the nation's premier drug safety experts, said a comprehensive drug safety system would be costly. ''A single complex study can cost over $2 million,'' Dr. Platt said.

The safety oversight board could nevertheless become an important avenue for earlier disclosures about potential problems with drugs on the market. The F.D.A. is required to keep secret much of the information it receives from drug companies about their products. But this information is often made public in advisory panel meetings, and such disclosures could become common with the drug oversight board.

''We need to find reasons to make the information available rather than simply saying we can't reveal trade secrets,'' Dr. Crawford said. ''We're in an era of openness.''